510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884481Substantially Equivalent

Clear Shot Angioplasty Balloon Inflation Device

Mallinckroot, Inc., St Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884481 is the FDA 510(k) clearance record for CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE, a class II device, cleared for Mallinckroot, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 7 510(k) clearances for Mallinckroot, Inc., from to . As of , FDA records show no recalls naming K884481.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Mallinckroot, Inc. 675 Mcdonnell Blvd. P.O. Box, St Louis MO
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260